Expandable devices for positioning organs

ABSTRACT

A positioning device is configured to selectively position or otherwise manipulate one or more organs within the body of a subject. The positioning device includes a shaped expandable element that is configured to be selectively transitioned between an unexpanded, or collapsed, state and an expanded state. While in the expanded state, the expandable element repositions or otherwise manipulates an organ. Systems that include positioning devices are also disclosed, as are methods for positioning or otherwise manipulating organs.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.15/684,938, filed on Aug. 23, 2017 and titled EXPANDABLE DEVICES FORPOSITIONING ORGANS (“the '938 Application”), now U.S. Pat. No.10,695,041, issued on Jun. 30, 2020, which is a continuation-in-part ofU.S. patent application Ser. No. 14/635,435, filed on Feb. 27, 2015 andtitled EXPANDABLE DEVICES FOR POSITIONING ORGANS (“the '435Application”), now U.S. Pat. No. 10,335,133, issued on Jul. 2, 2019. The'435 Application includes a claim for the benefit of priority to theFeb. 28, 2014 filing date of U.S. Provisional Patent Application No.61/946,392, titled EXPANDABLE DEVICES FOR POSITIONING ORGANS (“the '392Provisional Application”), under 35 U.S.C. § 119(e). The entiredisclosures of the '938 Application, the '435 Application, and the '392Provisional Application are hereby incorporated herein.

TECHNICAL FIELD

This disclosure relates generally to devices for selectively positioningor otherwise manipulating organs (e.g., hollow organs, organs adjacentto internal body cavities, etc.) within the body of a subject. Apositioning device according to this disclosure may include anexpandable element with a shape that will position a hollow organ, suchas an esophagus, in a desired manner. Systems that include organpositioning devices are also disclosed, as are methods for positioningorgans.

SUMMARY

A positioning device according to this disclosure may be configured forintroduction into a hollow organ or an internal body cavity and againsta surface of an organ. The positioning device may include a shaft and anexpandable element. The shaft may have a longitudinal axis, which maydefine the longitudinal axis of the positioning device. The shaft may beconfigured to enable introduction of the positioning device and, morespecifically, its expandable element, into the body of a subject andinto a hollow organ that is to be repositioned or otherwise manipulated.Alternatively, the shaft may be introduced into an internal cavitywithin a subject's body adjacent to at least one organ that is to berepositioned or otherwise manipulated.

The expandable element is positioned along a length of the shaft. It maybe located at an intermediate position along a length of the shaft, withportions of the shaft located proximal to and distal to the expandableelement. Alternatively, the expandable element may be located along adistal portion of the shaft or extend distally beyond a distal end ofthe shaft (e.g., the expandable element may be located at a distal endof the shaft, etc.).

The expandable element may have an unexpanded state and an expandedstate. The unexpanded state, or collapsed state, of the expandableelement may facilitate its introduction into a subject's body and intothe hollow organ or internal cavity, as well as its removal from thehollow organ or internal cavity and the body. While in the unexpandedstate, the expandable element may be flaccid or substantially flaccidand, thus, easily manipulated (e.g., bent, otherwise conform to adesired shape, etc.).

The expanded state of the expandable element may enable it to assume adesired shape, which may provide the positioning device with anasymmetrical structure. In some embodiments, the expandable element mayinclude a divergent section, a spacing section and, optionally, aconvergent section. The divergent section of the expandable element mayat least partially diverge from the longitudinal axes of the shaft andthe positioning device while in the expanded state. The spacing sectionof the expandable element, which is distal to the divergent section, maybe configured to move, stretch or otherwise manipulate the tissues of ahollow organ in which the expandable element is disposed or an organagainst which the expandable element is positioned and, thus, to modifythe position and/or shape of the organ. In embodiments where thepositioning device includes a convergent section, the convergent sectionmay reinforce the new position and/or shape of a portion of the holloworgan in which the expandable element resides or against which theexpandable element has been positioned, as defined at least in part bythe spacing section. The various sections of the expandable element maybe substantially linear and orientated at angles relative to oneanother. The corners between the sections of such an angular arrangementmay provide structural support that might not be present in embodimentswhere curved transitions exist between adjacent sections of theexpandable element. The abilities of the divergent section, the spacingsection, and any optional convergent section to move, reshape, orotherwise manipulate an organ or a portion thereof may, in someembodiments, result from a substantial rigidity (e.g., the rigidityprovided by a gas inflated (e.g., to a pressure of about 8 atm. to about15 atm., etc.) or fluid inflated element, etc.) or a rigidity of theexpandable element while in its expanded state.

In some embodiments, the expandable element may be formed from acompliant material (e.g., an elastic material, etc.). In otherembodiments, the expandable element may be formed from a less compliantmaterial or from a non-compliant material (e.g., a substantiallyinelastic material, an inelastic material, etc.), which may be pliableor flexible but substantially inelastic. When the expandable element ofa positioning device is formed from a non-compliant material, theextent, or distance, to which the spacing section of the expandableelement is moved away from a proximal section of the expandable elementand, thus, the extent to which an organ or a portion of an organ may bemoved, deflected, or diverted may be determined, at least in part, by anamount of pressure applied to an inflation medium (e.g., a gas, amixture of gases, air, a liquid, etc.) within the expandable element.

In use, the expandable element of a positioning device, while in itsunexpanded state, may be introduced into the body of a subject, and intoan interior of a hollow organ or into an internal cavity of the body. Insome embodiments, the expandable element may be introduced into the bodyalong a guide wire. Regardless of whether or not a guide wire is used,the shaft of the positioning device may facilitate introduction of theexpandable element into the body at a particular location and in aparticular orientation within the hollow organ or internal cavity. Oncethe expandable element is in place within the hollow organ or internalcavity, it may be at least partially expanded. If needed or desired, theposition and/or orientation of the expandable element may be adjusted.Positional adjustment may be longitudinal, relative to a length of thepositioning device and/or a length of an organ or a cavity within whichthe expandable element is positioned. Orientational adjustment may berotational, about the longitudinal axis of the positioning device.Rotational adjustment of the expandable element may be effected byrotating the shaft of the positioning device and/or by rotating a styletover which the shaft of the positioning device resides. In embodimentswhere a partially expanded expandable element is moved or itsorientation is adjusted, the partially expandable element may beexpanded further—even fully expanded. Expansion of the expandableelement may move, stretch or otherwise manipulate some or all of thehollow organ or internal cavity. With an organ moved or otherwisemanipulated in a desired manner (e.g., to a desired extent, or distance,in a desired direction, etc.), other procedures may be performed. Afterthose procedures are complete, the expandable element may be returned toits unexpanded state, which may reverse movement or other manipulationof part or all of the organ. The expandable element may then be removedfrom the hollow organ or internal cavity, and the expandable element andthe positioning device may be removed from the body of the subject.

Other aspects, as well as features and advantages of various aspects, ofthe disclosed subject matter will become apparent to those of ordinaryskill in the art through consideration of the ensuing description, theaccompanying drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 illustrates an embodiment of a positioning device, which includesa shaft and an expandable element positioned over an intermediateportion of the shaft, with the expandable element in an unexpandedstate;

FIG. 2 illustrates the embodiment of positioning device shown in FIG. 1,with the expandable element in an expanded state;

FIG. 3 depicts another embodiment of positioning device, which includesa shaft and an expandable element positioned over a distal portion ofthe shaft, with the expandable element in an unexpanded state;

FIG. 4 depicts the embodiment of positioning device shown in FIG. 3,with the expandable element in an expanded state;

FIG. 5 shows yet another embodiment of positioning device, whichincludes a shaft and another embodiment of expandable element on theshaft, with the expandable element in an unexpanded state;

FIG. 6 shows the embodiment of positioning device depicted by FIG. 5,with the expandable element in an unexpanded state;

FIG. 7 provides a cross-sectional representation through a shaft of apositioning device and through a stylet on which the shaft of thepositioning device resides, taken transverse to longitudinal axes of theshaft and the stylet;

FIG. 8 provides a cross-sectional representation of an embodiment ofinteraction between a shaft of a positioning device and a stylet overwhich the shaft of the positioning device resides, taken along thelongitudinal axes of the shaft and the stylet; and

FIGS. 9 through 11 are radiographic images of use of an embodiment ofpositioning device according to this disclosure in a human esophagus.

DETAILED DESCRIPTION

With reference to FIGS. 1 and 2, an embodiment of a positioning device10 that incorporates teachings of this disclosure is illustrated. Thepositioning device 10, which is configured to move and/or manipulate aportion of a hollow organ within which it is positioned, includes ashaft 20 and an expandable element 30.

The shaft 20 of the positioning device 10 comprises an elongatedelement, and may include a longitudinal axis L, which may define alongitudinal axis of the positioning device 10. The shaft 20 isconfigured to enable introduction of the expandable element 30 into thebody of a subject, and placement of the expandable element 30 at adesired location and in a desired orientation within the body; forexample, within a hollow organ in the body. The shaft 20 may havesufficient flexibility to enable its movement along curved, eventortuous, paths through the body of a subject, to enable it to conformto the shape(s) of structures (e.g., organs, etc.) within which oragainst which it is positioned and/or to enable it to at least partiallyconform to the shape of the expandable element 30. Flexibility of theshaft 20 may also accommodate changes in the shape of the expandableelement 30 as the expandable element 30 expands and/or retracts.

Without limitation, the shaft 20 may comprise a catheter. Morespecifically, the shaft 20 may comprise an over-the-wire (OTW) catheter,which may be configured to be placed over and introduced into thesubject's body along a guide wire. Even more specifically, the shaft 20may comprise a 6 French (F) to 9 F catheter that is configured forintroduction on a 60 PPI to 90 PPI large braid guide wire with an outerdiameter of up to about 0.038 inch.

The shaft 20 may be configured to enable remote expansion and retractionof the expandable element 30. In embodiments where the shaft 20comprises a catheter, the shaft 20 may include a lumen that enables aninflation medium, such as a gas or mixture of gases, air or a liquid, tobe introduced into the expandable element 30 and/or withdrawn from theexpandable element 30. In other embodiments, the shaft 20 may beconfigured to accommodate one or more elements (e.g., a control wire,etc.) that enable mechanical expansion and/or retraction of theexpandable element 30.

As illustrated by FIGS. 1 and 2, respectively, the expandable element 30of the positioning device 10 has an unexpanded state and an expandedstate. In its unexpanded state, which is depicted by FIG. 1, theexpandable element 30 may reside on an outer surface 22 of the shaft 20without extending substantially beyond the outer surface 22 of the shaft20. As shown in FIG. 2, in its expanded state, the expandable element 30may extend beyond the outer surface 22 of the shaft 20. In addition,when the expandable element 30 expands, it may diverge from thelongitudinal axes L of the shaft 20 and the positioning device 10.

In the embodiment depicted by FIGS. 1 and 2, the expandable element 30includes, from its proximal side to its distal side, a divergent section32, a spacing section 34, and a convergent section 36. The expandableelement 30 may also include a distal portion 39. The divergent section32 may be configured to move a portion of a hollow organ within whichthe divergent section 32 resides out of its normal location or, in thecase of an elongated organ (e.g., an esophagus, a large intestine, aurethra, etc.), out of the normal path of the elongated organ. Thespacing section 34, which is distal to the divergent section 32, isconfigured to hold a portion of an organ within which it resides in aparticular position and/or in a particular shape. The convergent section36, which is adjacent to the distal side of the spacing section 34, maybe configured to hold the distal side of the spacing section 34 inplace. Optionally, the convergent section 36 may be configured toaccommodate organs or other structures within the body of a subject. Thedistal portion 39, if any, may be aligned with the longitudinal axis Lof the shaft 20. In a specific, but non-limiting embodiment, thedivergent section 32 of an expandable element 30 having an outerdiameter of 14 mm may be capable of offsetting the spacing section 34 upto 7.5 cm from the ends 31 _(p) and 31 _(d) of the expandable element 30when no external forces (other than ambient external forces, such as thepressure of the atmosphere, gravity, etc.) are exerted on the expandableelement 30. Within a subject's esophagus, such a configuration may exertsufficient force on the esophagus to offset a portion of the esophagusby at least 2 cm.

Various transitions, or bends, between differently oriented sections ofthe expandable element 30 (e.g., the transition between the divergentsection 32 and the spacing section 34, the transition between thespacing section 34 and the convergent section 36, the transition betweenthe convergent section 369 and the distal portion 39, etc.) may besmooth. The smoothness of one or more transitions may be configured toreduce or eliminate the likelihood of trauma (i.e., a transition may beatraumatic) during and after placement of the expandable element 30 inits expanded state. In some embodiments, a transition, or bend, maycomprise a curve. In other embodiments, a transition, or bend, mayinclude outer corners that are radiused.

In a specific embodiment, in which the positioning device 10 and itsexpandable element 30 are configured for insertion into and manipulationof a human esophagus, the expandable element 30 may have a length ofabout 14 cm to about 16 cm, with the spacing section 34, which islocated centrally along a length of the expandable element 30, beingabout 10 cm long. The divergent section 32 and the convergent section 36may be configured to move the spacing section 34 laterally (in theorientation depicted by FIGS. 1 and 2) to a location that issubstantially parallel to the longitudinal axis L, but with alongitudinal axis L₃₄ of the spacing section 34 being offset by about 15mm from the longitudinal axis L. Upon placing the expandable element 30in its fully expanded state, its spacing may have any suitable diameter.Without limitation, an outer diameter of the spacing section 34 of theexpandable element 30, when fully expanded, may be about 5 mm to about20 mm (e.g., about 7 mm, about 10 mm, (e.g., for nasal insertion into anesophagus, etc.) about 14 mm (e.g., for oral insertion into anesophagus, etc.), etc.).

The expandable element 30 may, in some embodiments, include one or moreradiopaque features 40, which may enable a clinician to determine theposition and, optionally, the orientation of the expandable element 30within a hollow organ of a subject's body. In other embodiments, theexpandable element 30 may comprise a radiopaque material (e.g., inembodiments where the expandable element 30 comprises a mesh, etc.).

As suggested previously herein, the expandable element 30 may beconfigured to be inflated with an inflation medium, such as a gas ormixture of gases, air or a liquid. An expandable element 30 that isconfigured for inflation may include ends 31 _(p) and 31 _(d) that aresealed against the shaft 20. The shaft 20 of a positioning device 10with an expandable element 30 may include an inflation/deflation lumen24 that communicates with an interior of the expandable element 30 and,thus, introduces an inflation medium into the expandable element 30 andremoves the inflation medium from the expandable element 30 by way ofone or more apertures (not shown) that extend through a wall of theshaft 20, from the inflation/deflation lumen 24 of the shaft 20 to anexterior of the shaft 20.

An expandable element 30 may be shaped in a desired manner, such as thatdepicted by FIGS. 1 and 2. Cross-sectionally, the expandable element 30may be circular, elliptical, have a teardrop shape, or have any othershape that will cause little or no trauma during and following expansionof the expandable element 30. The cross-sectional shapes and dimensionsof the divergent section 32, the spacing section 34, and the convergentsection 36 of the expandable element 30 may be substantially the same,or uniform. Accordingly, the expandable element 30 may be formed from amaterial that can be shaped as desired. Without limitation, the materialof an inflatable expandable element 30 may be moldable, capable of beingwelded with heat or ultrasonically, or otherwise formed into a desiredshape. In addition, the material from which the expandable element 30 isformed may be compliant, semi-compliant, or substantially non-compliantor non-compliant when the expandable element 30 is in its expandedstate. Examples of suitable compliant materials for use as at least aportion of the expandable element 30 include, but are not limited to,elastic polyethylenes and polyurethanes. Examples of suitablesemi-compliant materials that may be used to form at least a portion ofthe expandable element 30 include, but are not limited to, somepolyethylenes, polyethylene terephthalate, and some vinyl polymers.Examples of substantially non-compliant or non-compliant materials thatmay be used to form at least a portion of the expandable element 30include, but are not limited to, some polyethylenes and nylon. When anexpandable element 30 that is formed from a substantially non-compliantmaterial or a non-compliant material is fully expanded, it will assumeand maintain its predefined shape, whereas the sizes and shapes ofexpandable elements 30 that are formed from more compliant materials maynot be limited to any predefined shape (e.g., they may continue toexpand with increased pressure, their shapes may be manipulated evenwhen an inflation medium therein exerts a maximum pressure on them,etc.). Thus, the amount of pressure the inflation medium exerts on suchan expandable element 30 may dictate the expanded shape of theexpandable element 30 and the distance the spacing section 34 of theexpandable element 30 is diverted from the ends 31 _(p) and 31 _(d) ofthe expandable element 30.

As indicated previously herein, suitable media for expanding inflatableembodiments of expandable elements 30 include gases, gas mixtures, andair. Alternatively, the medium that is used to inflate an inflatableexpandable element 30 may comprise a saline solution. In someembodiments, the saline solution may include a radio-opaque material,such as barium or a barium salt.

As an alternative to inflatable expandable elements, an expandableelement 30 may be formed from a shaped mesh that surrounds at least aportion of the shaft 20. Without limitation, a shaped mesh may be formedfrom stainless steel, nitinol, or any other suitable material. The meshmay be formed (e.g., annealed, etc.) to substantially conform to theshape and dimensions of the shaft 20, to enable the expandable element30 to reside on the shaft 20 when the expandable element 30 is in itsunexpanded state. The mesh may also be formed to impart the expandableelement 30 with a predetermined shape and dimensions when put in itsexpanded state.

An expandable element 30 that is formed from or otherwise includes ashaped mesh may be mechanically expanded by any suitable, known meansfor expansion, such as one or more elements that introduce tension intothe shaped mesh to cause it to expand, and that enable the shaped meshto collapse when the tension is released, or relaxed. As a non-limitingexample, an expandable element 30 may include one or more control wires26 that are configured to mechanically expand and collapse theexpandable element 30. Each control wire 26 may comprise a somewhatrigid element that may extend through a lumen 24 of the shaft 20, andmay be actuated (i.e., pulled and/or pushed) from a location at or neara proximal end of the shaft 20. As the positioning device 10 is beingintroduced into the body of a subject, each control wire 26 may bepushed forward to a position that maintains the expandable element 30 inits unexpanded state around and close to the shaft 20. When theexpandable element 30 is at an appropriate location within a holloworgan, one or more control wires 26 may be pulled to expand one or moresections of the expandable element 30 a desired extent. Once use of thepositioning device 10 is no longer needed (e.g., when deflection orother reshaping of the hollow organ is no longer needed, etc.), eachcontrol wire 26 may be pushed, which will cause the expandable elementto collapse to its unexpanded state, thereby facilitating removal of theexpandable element 30 and the remainder of the positioning device 10from the hollow organ.

Some embodiments of expandable elements 30 may include individually, orseparately, inflatable sections (e.g., divergent section 32, spacingsection 34, convergent section 36, etc., may be configured to beinflated and deflated independently from one another). In embodimentswhere the sections 32, 34, 36 of the expandable element 30 areindividually inflatable, each section 32, 34, 36 may communicate with aseparate lumen 24 of a catheter that forms at least a part of the shaft20 and through which inflation and/or deflation of a section 32, 34, 36of the expandable element 30 may occur. In other embodiments, thesections 32, 34, 36 may be individually expandable and/or retractable bydedicated actuators (e.g., pull wires, etc.).

Expandable elements 30 with separately expandable sections 32, 34, 36may enable a clinician to selectively expand the expandable element 30in two or more sequences. As an example, and with continued reference toFIGS. 1 and 2, the spacing section 34 may be expanded first, causing thespacing section 34 to occupy space within the hollow organ. After thespacing section 34 has been at least partially expanded, one or both ofthe divergent section 32 and the convergent section 36 may be expandedto move the spacing section 34 and the portion of the hollow organwithin which the spacing section 34 resides. Such a configuration mayprovide for increased control over the manner in which a portion of ahollow organ or an entire hollow organ is manipulated, including,without limitation, the distance the hollow organ is diverted orotherwise moved from its original location.

Turning now to FIGS. 3 and 4, an embodiment of a positioning device 10′is illustrated that includes an expandable element 30′ that resemblesthe embodiment of expandable element 30 shown in FIGS. 1 and 2. A shaft20′ of the positioning device 10′ is, however, configured to beintroduced into a body of a subject, or into a hollow organ within abody of a subject, without the need for a guide wire. The shaft 20′ ofthe positioning device 10′ may, therefore, lack a lumen for receiving aguide wire (although it may include one or more lumens 24 forinflating/deflating the expandable element 30 or sections thereof or oneor more lumens 24 for accommodating control wires 26 or other elementsfor expanding and contracting the expandable element 30 or sectionsthereof).

Referring now to FIGS. 5 and 6, yet another embodiment of positioningdevice 10″ is shown. The positioning device 10″ includes a shaft 20″ andan embodiment of expandable element 30″ that comprises a divergentsection 32″ and a spacing section 34″, but lacks a convergent section 36(FIGS. 1 and 2).

Turning now to FIGS. 7 and 8, embodiments of features are shown thatenable a stylet 25 to rotate a shaft 20 of a positioning device 10 and,thus, to rotationally move an expandable element 30 of the positioningdevice 10. More specifically a keyed feature 24 k within a lumen 24 ofthe shaft 20 (e.g., a keyed feature 24 k that comprises a part of thelumen 24, a keyed feature 24 k defined by a structure that has beensecured in place within the lumen 24, etc.)_may have a configurationthat receives and that may be rotationally engaged by a complementarilykeyed portion 25 k of a stylet 25 over which the shaft 20 resides. Thestylet 25 may comprise a permanent feature of the positioning device 10,or it may be capable of assembly with and disassembly from a remainderof the positioning device 10. In the illustrated embodiment, the keyedfeature 24 k in the lumen 24 and the keyed portion 25 k of the stylet 25have square cross-sectional shapes, as illustrated by FIG. 7. Of course,a variety of other shapes may also be used to enable rotation of theshaft 20 and the expandable element 30 of a positioning device 10 byrotating a stylet 25 over which the positioning device 10 resides. Insome embodiments, the keyed feature 24 k in the lumen 24 and the keyedportion 25 k of the stylet 25 may be located at or near distal ends ofthe shaft 20 and the stylet 25, respectively. In other embodiments, thekeyed feature 24 k in the lumen 24 and the keyed portion 25 k of thestylet 25 may be located more proximally (e.g., about midway along aheight of the expandable element 30, at a location proximal to theexpandable element 30, etc.). In any event, when the keyed portion 25 kof the stylet 25 is properly positioned within the keyed feature 24 k inthe lumen 24, rotation, or torqueing, of a proximal end of the stylet25, which may be located outside of a subject's body, may cause theshaft 20 to rotate and, thus, cause rotation of the expandable element30 about a longitudinal axis of the stylet 25. Such an arrangement mayenable rotational positioning of the expandable element 30 to a desiredorientation within a hollow organ or a body cavity.

In use, as shown in FIGS. 9 through 11, a positioning device 10 (or anyother embodiment of positioning device) according to this disclosure,with its expandable element 30 in an unexpanded state (see, e.g., FIG.7) may be inserted into a body of a subject and introduced to a desiredlocation and at a desired orientation within the subject's body (e.g.,into a hollow organ; into a long organ, such as an esophagus E, a largeintestine, a urethra, etc.; into a cavity, such as a nasal cavity;etc.). Without limiting any aspect of this disclosure, insertion of theexpandable element 30 into the esophagus E may occur orally or nasally.Once the expandable element 30 is believed to be in the proper positionand, optionally, the proper orientation, it may be partially expanded orcompletely expanded to confirm that its position and, optionally,orientation are proper. The particular location and, optionally, theparticular orientation of the expandable element 30 within the subject'sbody may be determined during or after insertion by any suitabletechnique (e.g., radiography, etc.). If necessary, the position and/ororientation of the expandable element 30 may be adjusted until it is ata desired location and in a desired orientation. The orientation of theexpandable element 30 may be adjusted by rotating the positioning device10. The expandable element 30 may be at least partially retracted tofacilitate such adjustment. Alternatively, an assembly that includes twoor more expandable elements 30 with spacing sections 34 that areoriented to be offset in different directions may be used, and theexpandable element 30 that is in the desired oriented for moving oroffsetting an organ or a portion thereof may be selected from expansion.

With the expandable element 30 at an appropriate location within thesubject's body, the expandable element 30 (or the selected expandableelement 30) may be partially or fully, or completely, expanded, as shownin FIG. 8, to manipulate the body; for example, the organ within whichthe expandable element 30 resides or organs that are adjacent to acavity within which the expandable element resides (e.g., the esophagusE, etc.). The manner in which the expandable element 30 is expanded(e.g., the order in which its sections 32, 34, 36 are expanded, theextent to which the expandable element 30 or one or more of its sections32, 34, 36 are expanded, etc.) may be controlled. Without limitation,the expandable element 30 may be expanded in a manner that minimizestrauma, in a manner that provides desired movement or reshaping of theorgan in which the expandable element 30 resides, etc. In someembodiments, expansion of the expandable element 30 may be visualized(e.g., by radiography, etc.) to confirm that the manner and/or extent ofexpansion provides one or more desired results (e.g., minimization oftrauma, reshaping and/or movement to a desired extent, reshaping and/ormovement to a desired extent, etc.). An expandable element 30 and themanner in which it is placed in its expanded state may be configured tomove or otherwise manipulate a portion of a long, hollow organ withminimal or no movement of portions of the long, hollow organ that areproximal and distal to the expandable element 30; i.e., withoutdistending the long, hollow organ.

In some embodiments, including embodiments such as that depicted inFIGS. 1 and 2 where the expandable element 30 comprises a balloon withone or more sections formed from a substantially non-compliant materialor a non-compliant material, the angles between adjacent ends 31 _(p)and 31 _(d) and sections (e.g., divergent section 32, spacing section34, convergent section 36, etc.) may decrease as the expandable element30 is expanded (e.g., inflated, etc.), with each angle approaching 90°as the expandable element 30 is fully expanded. Thus, the pressure aninflation medium exerts on the expandable element 30 may at leastpartially determine the extent to which the spacing section 34 of theexpandable element 30 moves away from the divergent section 32 and theconvergent section 36 and, thus, the extent to which the expandableelement 30 may deflect a portion of a long, hollow organ. In a specific,but non-limiting, embodiment, an expandable element 30 with a 14 mmouter diameter and a spacing section 34 that is configured to be offsetby up to 7.5 cm from ends 31 _(p) and 31 _(d) of the expandable elementmay be expanded by an inflation medium (e.g., a gas, a mixture of gases,air, etc.) that exerts a pressure of about 4 atm. to about 8 atm. oninterior surfaces of the expandable element 30. It may be possible toachieve similar results using less pressure within expandable elements30 having smaller outer diameters.

FIG. 9 shows the movement achieved between the orientation of expandableelement 30 depicted by FIG. 7 (unexpanded) and the orientation ofexpandable element 30 depicted by FIG. 8 (expanded). In the embodimentillustrated by FIGS. 7 through 9, the esophagus E has been moved about32 mm away from the left atrium of the heart.

With the expandable element 30 holding the organ in a manipulated state,another procedure may be conducted. As a non-limiting example, anexpandable element 30 may deflect an appropriate portion of an esophagusE away from the left atrium of the heart during a left atrial ablationprocedure. As another non-limiting example, an expandable element 30 maydeflect an appropriate portion of a large intestine or a urethra awayfrom a prostate during biopsy or surgical treatment of a prostate.

Once the surgical procedure is complete or manipulation of the organ isno longer needed, the expandable element 30 may be collapsed around theshaft 20 of the positioning device 10. The expandable element 30 and theremainder of the positioning device 10 may then be removed from thesubject's body.

Although the foregoing disclosure provides many specifics, these shouldnot be construed as limiting the scope of any of the ensuing claims.Other embodiments may be devised which do not depart from the scopes ofthe claims. Features from different embodiments may be employed incombination. The scope of each claim is, therefore, indicated andlimited only by its plain language and the full scope of available legalequivalents to its elements.

What is claimed:
 1. A positioning device capable of introduction againstan interior surface of an organ, comprising: a shaft with a longitudinalaxis; and a deflector at a distal end of the shaft, the deflectorincluding a series of sections with the series of sections beingoriented at different angles from one another in a manner that enablesthe deflector to change a path of the organ, with corners having obtuseangles being defined at junctions between adjacent sections of theseries of sections, the deflector being: substantially flaccid in anunexpanded state and substantially rigid in an expanded state; andasymmetrical about the longitudinal axis in the expanded state such thatthe positioning device, in the expanded state, is capable ofrepositioning the organ.
 2. The positioning device of claim 1, whereinthe deflector, in the expanded state, includes: a diverting section thatextends away from the longitudinal axis.
 3. The positioning device ofclaim 2, wherein the deflector, in the expanded state, further includes:a spacing section distal to the diverting section, at least a portion ofthe spacing section having a central axis oriented substantiallyparallel to the longitudinal axis.
 4. The positioning device of claim 3,wherein the deflector, in the expanded state, further includes: aconvergent section distal to the spacing element and extending towardthe longitudinal axis.
 5. The positioning device of claim 1, whereinsections of the series of sections have cross-sectional shapes anddimensions taken transverse to lengths of the sections that are uniformand substantially the same as one another.
 6. The positioning device ofclaim 1, wherein the deflector is inflatable.
 7. The positioning deviceof claim 6, wherein the shaft includes a lumen for communicating aninflating medium into a cavity of the deflector to transition thedeflector from the unexpanded state to the expanded state.
 8. Thepositioning device of claim 1, further comprising: a stylet capable ofchanging at least one of a position, an orientation, and a configurationof the deflector within the organ.
 9. The positioning device of claim 1,further comprising: a stylet capable of rotating the positioning device.10. A positioning device capable of introduction against an interiorsurface of a hollow organ, comprising: a shaft with a longitudinal axis;a deflector at a distal end of the shaft, the deflector conformable toan expanded state divert a path of the hollow organ, the deflectorincluding, in series: a diverting section that extends away from thelongitudinal axis; a spacing section oriented at an angle to and distalto the diverting section, at least a portion of the spacing sectionbeing oriented substantially parallel to the longitudinal axis; and aconvergent section oriented at an angle to and distal to the spacingsection and extending toward the longitudinal axis, corners havingobtuse angles being defined between the diverting section and thespacing section and between the spacing section and the convergentsection upon conforming the deflector to the expanded state.
 11. Thepositioning device of claim 10, wherein the deflector comprises aninflatable deflector having a deflated configuration and an inflatedconfiguration.
 12. The positioning device of claim 11, wherein thedeflector is flaccid in the deflated configuration and substantiallyrigid in the inflated configuration.
 13. The positioning device of claim10, wherein cross-sectional dimensions of the diverting section, thespacing section, and the convergent section, taken transverse to lengthsthereof, are uniform and substantially the same as one another.
 14. Thepositioning device of claim 10, further comprising: a stylet capable ofrotating the positioning device.
 15. A method for moving a portion of ahollow organ away from another organ, comprising: inserting a shapabledeflector into the hollow organ, the shapable deflector including aseries of sections; positioning and orienting the shapable deflector tomove the portion of the hollow organ away from another organ; expandingthe shapable deflector, including orienting the series of sections, toincrease a rigidity of the shapable deflector, to define corners havingobtuse angles between adjacent sections of the series of sections tochange a path of the hollow organ to move the portion of the holloworgan away from the another organ.
 16. The method of claim 15, furthercomprising: conducting a procedure on the another organ with the portionof the hollow organ deflected away from the another organ.
 17. Themethod of claim 15, further comprising: changing at least one of aposition, an orientation, and a configuration of the shapable deflectorwithin the portion of the hollow organ.
 18. The method of claim 15,further comprising: collapsing the shapable deflector; and removing theshapable deflector from the hollow organ.
 19. The method of claim 15,wherein expanding the shapable deflector includes expanding the shapabledeflector to provide each section of the series of sections withsubstantially the same uniform cross-sectional shape and dimensions,taken transverse to the length of that section, as the uniformcross-sectional shape and dimensions as each other section of the seriesof sections.
 20. The method or claim 15, wherein expanding the shapabledeflector enables movement of the hollow organ without distension of thehollow organ.